Kornimate/medical-research-clean huggingface dataset:
treatment of fecal incontinence and chronic constipation with low-volume irrigation

Conditions: Constipation; Fecal Incontinence

Summary: the aim of this study is to investigate the efficacy of low-volume irrigation on bowel function among patients with fecal incontinence and/or chronic constipation (of heterogenous origin).

the aim of this study is to investigate the efficacy of low-volume irrigation on bowel function among patients with fi and/or cc (of heterogenous origin). further, the aim is to investigate if low volume irrigation can change the negative impact that symptoms of fi and/or cc (of heterogenous origin) have on the patients' daily activities and qol. additionally, the aim is to investigate the short-term and long-term discontinuation rates in relation to treatment with low-volume irrigation. finally, the aim is to investigate the daily time-consumption, the practical challenges and the side effects related to low-volume irrigation. the study period is six weeks and the participants will be instructed to irrigate once daily with qufora irrisedo minigo. this study is an interventional study. patients with fi and/or cc of heterogenous origin, seen in the nurse-led clinic for bowel dysfunction at the pelvic floor unit, aarhus university hospital, will be included. patients will be offered transanal irrigation as a treatment option. patients presenting with bristol stool type 6-7 should be offered conservative treatment to optimize the stool consistency. if patients can be regulated to a bristol stool type 1-5, they can be invited to participate in the study. if necessary, regulation of the stool consistency in patients presenting with bristol stool type 1-2 is an option, before introducing transanal irrigation.

Eligibility criteria:
inclusion criteria: * patients with fi, cc or co-existing fi and cc of heterogenous origin. * positive rome iv criteria for constipation and/or positive rome iv criteria for fecal incontinence. * patients with bristol stool type 1-5 as their primary stool consistency. * 18 years. * ability to understand written and spoken danish (due to questionnaire validity). exclusion criteria: * prior use of transanal irrigation or mini enema. * patients with chronic diarrhea (bristol stool type 6-7). * patients with neurogenic bowel dysfunction. * participation in research conflicting with the current study. * diseases treated with rectal or anal surgery (except minor rectal or anal surgery). * physical disability that affects the ability to use quforaò irrisedo minigo. * major psychiatric diagnoses. * patients with constipation with a chronic opioid use or other medications inducing constipation. * pregnancy or plans to become pregnant.
study of single and ten day repeat atopical applications of gw842470x cream on the skin of patients with atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: the purpose of this study of this study is to investigate the safety, tolerability and pharmacokinetics of gw842470x in patients with atopic dermatitis. gw842470x is an inhibitor of phosphodiesterase 4 (pde4).


Eligibility criteria:
inclusion criteria: * atopic dermatitis patients (moderate to severe) who are otherwise healthy. * bmi range 18.5-29.9m2 at least 2 index lesions and bsa involvement \>10%. * 14 day washout of current therapy. exclusion criteria: * patients who have had systemic treatment for atopic dermatitis or other topical or transdermal treatments (such as nicotine, hormone replacement therapies) within 14 days prior to first application of study medication and/or topical treatment with tar or any treatment with corticosteroids within 14 days prior to first application except 1% hydrocortisone. * patients must not present with any systemic disorders or active skin disease other than atopic dermatitis.

Keywords: pk gw842470x safety tolerability pd atopic dermatitis
belgian prospective multicentre registry to evaluate safety and performance of the optimed stent in the superficial femoral artery

Conditions: Peripheral Arterial Disease

Summary: this is a belgian prospective multicentre registry to evaluate safety and performance of the sinus-superflex-visual stent (optimed) in superficial femoral artery (sfa) atherosclerotic lesions. target number is 500 patients in approximately 11 centres. patients will be followed for a period of 2 years.


Eligibility criteria:
inclusion criteria: * signed informed consent * stenosis (\> 75%) or occlusion of the superficial femoral artery (lesion up to 3 cm distal to hunter's canal and 4 cm proximal to the patella) * tasc ii (2007)type a, b or c lesions * target vessel diameter between 4.5 and 7 mm * debilitating claudication or critical limb ischemia (rutherford 2 to 5) * at least 1 outflow vessel down to the ankle * patient is at least 18 years old * life expectancy \> 2 years * patient is compliant with the requested follow-up visits exclusion criteria: * no informed consent * rutherford 6 * tasc ii type d lesions * patient is not 18 years old * patient is pregnant * acute ischemia * patient is not compliant with the requested follow-up visits * unable to cross target lesion with guidewire * patient is allergic to nickel-titanium * presence of an aneurysm in the sfa

Keywords: stent atherosclerotic occlusive disease peripheral arterial disease superficial femoral artery sfa
driving pressure in trauma

Conditions: Sever Chest Trauma; Mechanical Ventilation

Summary: traumatic chest injuries are responsible for significant morbidity and the cause of trauma-related death in 20%-25% of cases. thoracic trauma can include multiple injuries, mainly osseous (ribs, sternal fractures, flail chest), pulmonary contusions or lacerations, pneumothoraces and pleural effusions, and sometimes involve wounds to the heart and vessels (aortic dissection, cardiac contusion) or diaphragm. following trauma, patients with thoracic injuries are at risk of developing acute respiratory distress syndrome (ards). this worsening of respiratory function can lead to requirement for mechanical ventilation. in addition, changes to gas exchange may also be generated or aggravated by mechanical ventilation as a result of barotrauma, biotrauma, or ventilation-associated pneumonia. many mechanical ventilation strategies have been tried in trauma patients in the last 30 years to determine the optimal method of maximizing gas exchange with minimal lung damage. the driving pressure of the respiratory system has been shown to strongly correlate with mortality in a recent large retrospective ardsnet study. respiratory system driving pressure \[plateau pressure-positive end-expiratory pressure (peep)\] does not account for variable chest wall compliance especially in cases of chest trauma. esophageal manometry can be utilized to determine transpulmonary driving pressure. a recent study suggests that utilizing peep titration to target positive transpulmonary pressure via esophageal manometry causes both improved elastance and driving pressures. treatment strategies leading to decreased respiratory system and transpulmonary driving pressure at 24 h may be associated with improved 28 day mortality. however, currently no specific study with chest trauma patients exists. we propose to investigate the effect of hight transpulmonary driving pressure on duration on mechanical ventilation, length of stay and mortality in patients with sever chest trauma.


Eligibility criteria:
inclusion criteria: * major patients (18-90 years old) * affiliated to the social security * hospitalized following severe trauma chest trauma * mechanical ventilatory support for a minimum of 72 hours exclusion criteria: * minor patients, * patients under tutorship / curatorship, * pregnant or lactating women

Keywords: thoracic trauma mechanical ventilation acute respiratory distress syndrome esophageal pressure pleural pressure
clinical efficacy of a chlorhexidine-based mouth-rinse containing citrus aurantium amara

Conditions: Wound Healing

Summary: the primary objective of the study is the evaluation of efficacy of a mouthwash cointaining chlorexidine (chx) 0.09% + ha + citrox (test group) on the quality of wound healing and the presence plaque formation and gingival inflammation in the post-surgical phase. futhermore stains, discolorations and adverse effects will be eventually recorded. control group will be represented by the use of a chx 0.12% mouthwash.


Eligibility criteria:
inclusion criteria: * more than 20 natural teeth excluding the third molars * clinical indication for a surgical intervention for the treatment of at least one residual pocket after non-surgical therapy (pocket depth (pd) ≥5mm) * have a full mouth plaque score (fmps) \<15% before surgery; * have a full mouth bleeding score (fmbs) \<15% before surgery; * ability and willingness to give written informed consent; * written agreement to participate in the trial. exclusion criteria: * use of medications, such as anti-platelet or anti-coagulant agents, any other concomitant systemic disorder, cardiovascular and diabetes diseases, allergic, infectious diseases and medications affecting periodontal inflammation * pregnancy or breastfeeding; * use of medication affecting the healing process; * assumption of systemic or local antibiotics in the 4 weeks before trial beginning; * conditions of the teeth or of the site that contraindicate the surgery (severe mobility, fractures, untreated endodontic lesions, incongruous restorations); * patients with previous periodontal treatment or who were undergoing a course of dental or orthodontic treatment will be also excluded. * tobacco use (10 or more cigarettes per day) * inability to comply with protocol * uncooperative patient
a feasibility study of an ai-powered clinical decision aid for personalized depression treatment selection

Conditions: Depression

Summary: the clinical decision aid (cda) is a predictive model that takes as input individual patient characteristics, called 'features', which are inputted by the physician or by patient self-report, and outputs a list of possible treatments, with each treatment associated with a predicted efficacy (likelihood to achieve response and likelihood to achieve remission, each expressed as a percentage). the treatments, which may include any approved treatment for depression, will be presented to the physician who will then make a treatment choice.

hypothesis 1. there will not be a significant difference in measured non-initial intake appointment lengths between the baseline period and the appointment length measured at two and four months after introduction of the study software and cda. hypothesis 2. physicians will not subjectively report that using the cda and study software increased the length of their appointments. hypothesis 3. at least 66% of patients and 66% of physicians will rate the trustworthiness of the cda as a 4 or 5 on a 5 point likert scale (with higher ratings indicating greater trust). hypothesis 4. at least 66% of patients and 66% of physicians will rate the overall usability of the cda as a 4 or 5 on a 5 point likert scale (with higher ratings indicating greater usability). hypothesis 5. at least 70% of physicians and 65% of patients will still be using the application regularly by the end of the study. for physicians, regularly will be defined as the application being used in every study-related visit. for patients regularly will be defined as completing at least one phq-9 and gad-7 questionnaire on the application per week. exploratory hypothesis: based on our machine learning results to date, we expect between 40-50% of patients starting a new treatment for depression and whose treatment follows the highest probability treatment output by the cda to remit within 14 weeks. this is exploratory, and the study is not necessarily powered to demonstrate this.

Eligibility criteria:
inclusion criteria: * all patients of the physicians in the study are diagnosed with major depressive disorder by a physician using dsm-v criteria. * all participants must be able to provide informed consent. * contraception will be used as per established clinical guidelines and usual clinical practice for medications known to cause birth defects. the medications prescribed and the use of and type of contraception will be determined by the physicians in the study in consultation with their patients as would usually occur in clinical practice. exclusion criteria: * bipolar disorder type 1 or 2, as the data we have used to train the model does not allow for generalization to bipolar disorder (either pre-existing or as diagnosed according to dsm-5 criteria). * inability or unwillingness of individual to give informed consent.

Keywords: artificial intelligence deep learning clinical decision aid
comparison of the effectiveness of intradialytic core stabilization and aerobic exercise in hemodialysis patients

Conditions: Hemodialysis Complication

Summary: purpose: to examine the effects of core stabilization and aerobic exercises on dialysis adequacy, functionality level, and quality of life in hemodialysis (hd) patients. the secondary aim of the study is to compare the effectiveness of intradialytic core stabilization and aerobic exercises in hd patients. materials and methods: patients who received hemodialysis treatment for 4 hours, 3 days a week were planned to be included in this randomized controlled study. patients participating in the study will be randomly divided into 2 groups. grup 1 was planned to be given core stabilization exercises during hemodialysis three times a week for eight weeks; group 2 was planned to be given aerobic exercise during hemodialysis three times a week for eight weeks. it aimed to evaluate the patients in the weeks before the start of the treatment and the week after the end of the treatment. personal information form for evaluation, dialysis adequacy, quality of life questionnaire-kidney disease quality of life-36, piper fatigue scale, hospital anxiety and depression scale (hads), pittsburgh sleep scale, five times sit and stand test, 10 m walking test , tinetti balance and walking test, and 2-minute step test were planned to be used.


Eligibility criteria:
inclusion criteria: * to receive hd treatment for a minimum of 6 months, for 4 hours per day, three days per week * being 18 years or older * a score of 3 and/or below in the sarcopenia screening test (sarc-f) exclusion criteria: * having a history of myocardial infarction in the last 3 months * having angina pectoris, arrhythmia, or uncontrolled hypertension * having communication and/or cognitive issues that prevent them from meeting the requirements of the tests * becoming pregnant or going through infertility treatment * having a psychiatric diagnosis

Keywords: hemodialysis dialysis efficiency fatigue quality of life sleep functionality
a thin catheter for hystrosalpingography

Conditions: Infertility

Summary: the investigators will use a thin catheter for hsg and apply pressure on the cervix with the vaginal speculum to prevent leakage of the dye during injection to study the uterine cavity and fallopian tubes and reduce the pain as compared to a standard metal cannula.

hysterosalpingography (hsg) remains one of the most reliable methods to study tubal patency and the uterine cavity (1-3). the relative indications and importance of hsg and laparoscopy in the diagnosis of tubal factor infertility have been extensively discussed. recently a multicenter randomized controlled trial (4) has demonstrated that the routine use of hsg at an early stage of infertility work up, prior to laparoscopy and dye, does not influence the cumulative pregnancy rate compared with the routine use of laparoscopy and dye alone. however, hsg is an efficient method which is less invasive and less costly than laparoscopy (5), and than transvaginal hydrolaparoscopy (6). the main disadvantages of hsg are being unable to confirm adhesions, endometriosis and being a painful procedure (7,8). different cannulas and catheters have been tried to reduce pain such as the rubin cannula (9), jorcho cannula (10), and whitehead cannula or foley catheter (11). minimal difference in the degree of pain was found when the balloon catheter was compared with the cervical cup (12). general and local medications have been tried to alleviate pain during the procedure. (3,13). hsg is widely practiced in our country, however, for cost effective reasons, the standard metal cannula is the only method used at our hospital. it is painful procedure because it requires grasping the cervix with a tenaculum and inducing some cervical dilatation during introduction of the cannula. the aim of this pilot study was to develop a simple and painless technique for hsg using a thinner than normal catheter, and without grasping the cervix with a tenaculum. leakage of the dye through the cervix was prevented by pressing on the portiovaginalis of the cervix using the vaginal speculum. this technique for performing hsg is a novel one and has not been described previously in the medical literature.

Eligibility criteria:
inclusion criteria: * infertile women during their fertility workup and requesting to do hysterosalpingography exclusion criteria: * women with pelvic inflammatory disease

Keywords: infertility fallopian tubes
pre-salpingo-oophorectomy pilot study of mako 7 device performance

Conditions: BRCA1 Mutation; BRCA2 Mutation; Atypia Suspicious for Malignancy

Summary: this study evaluates the ability of the mako 7 device to collect various cells

prospective, multi-center observational study to evaluate the ability of the mako 7 device to collect cells from the fallopian tubes for cytological evaluation for determination and/or differentiation of normal versus atypical versus malignant cells.

Eligibility criteria:
inclusion criteria: 1. subject is medically cleared for surgery 2. subject is scheduled to undergo a salpingo-oophorectomy for a pelvic mass suspicious for malignancy or for brca1 or brca2 mutations 3. subject must be 18 years of age 4. subject must be able to provide informed consent exclusion criteria: 1. contraindication to hysteroscopy 2. acute pelvic inflammatory disease 3. active or recent lower pelvic infection 4. pregnancy 5. delivery or termination of a pregnancy in the past 6 weeks 6. known tubal obstruction including tubal ligation 7. invasive carcinoma of the cervix or endometrium 8. intolerance of anesthesia
endotracheal tube (ett) 180: stylet-loaded endotracheal tube rotation before insertion

Conditions: Anesthesia, Endotracheal

Summary: the main objective of the proposed study is to clarify whether rotating a stylet-loaded endotracheal tube (ett) 180 degrees prior to intubation will decrease the incidence of postoperative throat soreness, when compared to standard technique used in standard of care.

the researcher who is not blinded will randomize the patient to one of the three groups. specific technique and procedure: * investigators anesthesiologists assigned to perform the laryngoscopies will be limited to 6 with minimum 2 years of attending experiences to balance the variability. the results of inter-operator bias will be analyzed. * endotracheal tube (ett) size will be: 7.0 for men and women unless there will be clinical indications to use a different size of endotracheal tube. * stylet preparation: 75-degree angulation shaped preoperatively and ready for use * blade for either mcgrath, macintosh, or direct laryngoscopy will be size 3 for women and size 4 for men. * endotracheal tube (ett) 180: inserting endotracheal tube loaded with stylet, rotating the tube 180 degree clockwise as soon as the tube tip passes the vocal cords (glottis), and removing the stylet after the tube cuff passes through the vocal cords, which is a common practice. * endotracheal tube cuff filling air pressure will be 20 cmh2o. inflation will be made using a hand-held airway pressure manometer. * patient's data collection will be blinded for both patient and investigators anesthesiologists assigned to perform the laryngoscopies * no medications including opiates, monitoring options, and medical decisions will be altered by the study. a member of the research team will follow-up (in person or phone-call) with each patient in the post anesthesia care unit (pacu) and 24+/- 3 hours after endotracheal tube removal to collect information regarding any symptoms of hoarseness or sore throat.

Eligibility criteria:
inclusion criteria: * asa i - iii * ambulatory patients undergoing general anesthesia with an endotracheal tube (ett) placement * admitted patients undergoing general anesthesia an endotracheal tube (ett) placement * age \> 18 and \< 90 years old * bmi \< 50 exclusion criteria: * age \ 90 years old * pregnant women * prisoners * any surgery involving the pharynx, larynx, vocal cords, trachea that will create confounding factors related to postoperative sore throat * history of difficult airway * critically ill patients requiring intensive care
a multicenter prospective observational study to derive and verify the performance of a host-response based diagnostic tool for early detection of severe infections.

Conditions: Sepsis; Acute Infection

Summary: the study is a multi-center, prospective, observational clinical study enrolling patients from at least 3 medical centers. study population will include patients over the age of 18 years. the study will recruit patients presenting with suspicion of acute infection/sepsis and healthy individuals. study main objective is to derive and verify a host response based score to predicte severe outcome.

for determining disease severity each enrolled patient will be assigned as either "severe outcome patient" or "non severe outcome patient" according to predefined criteria. (or "healthy"). participation in the study requires the collection of routine patient data and blood sample. blood samples will be used for measurements of host biomarkers that predict disease severity. the blood samples will be collected upon enrollment. in addition, a standardized patient questionnaire inquiring about severity outcomes met up to 28 days after presentation will be conducted by phone call 28 to 42 days post admission. enrolled patients will be managed according to the current standard of care per standard institutional procedures. results of the measured biomarkers will not be revealed to the attending clinician and so will not influence patient management.

Eligibility criteria:
suspected acute infection/sepsis patients patients eligible for inclusion are required to fulfill all of the following criteria: * written informed consent must be obtained from the patient or his/her legal guardian. * over 18 years of age * clinical suspicion of acute infection/sepsis as defined by the attending physician, based on clinical presentation. healthy individuals patients eligible for inclusion are required to fulfill all of the following criteria: * written informed consent must be obtained from the patient * over 18 years of age * no clinical suspicion of acute infection. exclusion criteria: suspected acute infection/sepsis patients patients fulfilling the following criteria are not eligible for inclusion in this study: * hiv, hbv, active hcv or active tuberculosis infection (self-declared or known from medical records). * pregnancy- self reported or medically confirmed. healthy individuals patients fulfilling the following criteria are not eligible for inclusion in this study: * episode of infection in the last 2 weeks * major trauma and\\or burns and\\or surgery in the last 2 weeks * hiv, hbv, active hcv or active tuberculosis infection (self-declared or known from medical records) * elective surgery patients * pregnancy- self reported or medically confirmed

Keywords: host response suspected sepsis suspected acute infection biomarkers ards septic shock sepsis associated aki